Evaluation of Interventions in Post-Acute Sequelae of SARS-CoV-2 Infection

What is the Purpose of this Study?

This study aims to determine whether antiviral or other drugs can help people who have COVID symptoms that have lasted more than 3 months after a COVID infection, a condition known as post-acute sequelae of SARS-CoV-2 infection, including long COVID. Participants will be randomly assigned to 1 of 2 groups. One group will receive Paxlovid, a combination of 2 nirmatrelvir pills and 1 ritonavir pill. The other group (control group) will receive a combination of 2 placebo pills (inactive substance) and 1 ritonavir pill. Researchers will study the effects that Paxlovid may have on patients’ ability to recover from long COVID. The use of Paxlovid, nirmatrelvir and ritonavir is considered investigational in this study.

Eligibility

≥ 18 years of age at the time of enrollment
Previous suspected, probably or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization*

Inclusion Criteria:

≥ 18 years of age at the time of enrollment
Previous suspected, probably or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization*
*Suspected and probable cases will only be allowed if it occurred before May 1, 2021, and will be limited to 10% of the study population. Otherwise, confirmed cases are required.
Suspected case of SARS-CoV-2 infection - Three options, A through C:
A. A person who meets the clinical OR epidemiological criteria. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or
B. Acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization); or
C. With no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test.
Probable case of SARS-CoV-2 infection:
A. A patient who meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster.
Confirmed case of SARS-CoV-2 infection - Two options, A through B:
A. A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or
B. Meeting clinical criteria AND/OR epidemiological criteria (See suspect case A). With a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
At least two moderate symptoms from the same symptom cluster or one severe cluster-associated symptom identified via the Cluster Targeted COVID-19 Symptom Questions (CTCSQ), with participant identifying new symptoms since COVID-19 illness and having persisted for at least 12 weeks
Meeting PRO Symptom Cluster criteria for at least one Symptom Cluster
Willing and able to provide informed consent, complete the surveys, clinical assessments, and return for all of the necessary follow-up visits

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study. Refer to appendices for additional appendix-level criteria:
Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
Known severe anemia, defined as < 8 g/dL
Meeting the following symptom cluster exclusion for all eligible clusters*:
a. Cognitive dysfunction: known stroke that resulted in cognitive impairment within 3 months of enrollment b. Autonomic dysfunction: atrial fibrillation or significant cardiac arrhythmia, more than moderate alcohol consumption**, pre-existing sustained severe hypertension (BP> 180/110 mmHg in the sitting position) c. Exercise intolerance: i. any of the following within 4 weeks of consent - an acute myocardial infarction or unstable angina, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema), acute pulmonary embolism, suspected dissecting aneurysm, severe hypoxemia at rest, any acute or chronic disorder that may affect exercise performance ii. if the participant is aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate)
** Defined as greater than 2 drinks a day for men and 1 drink a day for women. A drink is equivalent to 12 ounces of beer (5% alcohol content), 8 ounces of malt liquor (7% alcohol content), 5 ounces of wine (12% alcohol content), 1.5 ounces or a "shot" of 80-proof (40% alcohol content) distilled spirits or liquor (e.g., gin, rum, vodka, whiskey). 21
Known diagnosis of chronic Lyme disease with persistent symptoms, sequelae, or related therapy
Any non-marijuana illicit drug use within 30 days of informed consent
Current or recent use (within the last 14 days) of study intervention*
Known allergy/sensitivity or any hypersensitivity to components of the study intervention (s) or control*
Known contraindication(s) to study intervention(s),
Inability to discontinue symptomatic medications for the identified time periods
Moderate or severe immunocompromised patients, such as those described in the NIH COVID-19 Treatment Guidelines (https://www.covid19treatmentguidelines.nih.gov/ special populations/immunocompromised/)
Currently enrolled in another clinical trial outside this platform protocol or another study intervention appendix in this platform protocol***
***Participants may re-enroll in the trial for a different study intervention appendix if the participant has completed an appropriate washout period and efficacy has been determined for the appendix in which the participant was previously enrolled.
Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
If only one study intervention appendix is open at the time of enrollment. If multiple study intervention appendices are open, a participant may be excluded from any study intervention appendix based on contraindications listed in the study intervention appendix, current use of study intervention, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study intervention appendices.

Show less

Where can I participate?

Beverly : Antonina Caudill

More about this Clinical Trial

What is the full name of this clinical trial?

RECOVER-VITAL: A Platform Protocol for Evaluation of Interventions for Viral Persistence, Viral Reactivation, and Immune Dysregulation in Post-Acute Sequelae of SARS-CoV-2 Infection

Study Details

Disease Type/Condition

COVID-19

Principal Investigator

Chen, Peter

Age Group

Adult

Phase

IRB Number

STUDY00002842

ClinicalTrials.gov ID

NCT05595369

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Antonina Caudill

Antonina.Caudill@cshs.org